Dimension® TNI CAL

Basic Information

• Brand Name: Dimension® TNI CAL
• Primary DI: 00842768022074
• Version / Model: 10464336
• Catalog Number: RC621
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: 7d8a4c66-5752-4098-9a34-e87b6d80d2b5

Device Description

LOCI Cardiac Troponin I Calibrator, 2x5x2mL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIT	CALIBRATOR, SECONDARY	Clinical Chemistry	862.1150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54011	Troponin I IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of troponin I in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768022074	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K081683	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius